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Completed

NCT Number: NCT00196599

Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults

In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Such therapy induces side effects and the number of pills may reduce therapy adherence. The aim of this study is to evaluate the efficacy and the safety of a once daily FTC, ddI, efavirenz combination, in HIV patients with CD4 cell count over 100/mm3, antiretroviral naive.

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Key information

Conditions

HIV Infections Antiretroviral Naive Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service de Maladies Infectieuses, Hôpital Saint-Louis

Paris, 75475, France

About this study

In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Side effects of this products and the number of pills may induce a lower adherence, and thus a lower efficacy. 40 patients with a CD4 count over 100/mm3, a HIV RNA over 5,000 copies/ml and antiretroviral naive, take the once daily combination of FTC, ddI, efavirenz during 24 weeks. The primary end-point is the viral success maintained from 12 weeks until 24 weeks. Secondary end-point is the adherence to the association and safety.

The trial is prolonged during a total of 72 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV infection
  • Antiretroviral naive
  • CD4 cell count over 100/mm3
  • Plasma HIV RNA load over 5,000 copies/mL
  • Signed written informed consent

Exclusion criteria

  • Hepatitis B infection
  • Pregnancy
  • Alcool abuse
  • Acute infection, past neurological or pancreatic disease, biological abnormalities
  • Chemotherapy or immunotherapy

Treatment and study plan

emtricitabine, FTC (drug)

Drug

didanosine, ddI (drug)

Drug

efavirenz (drug)

Drug

Primary outcomes

  1. Virological success

Secondary outcomes

  1. Treatment adherence

  2. CD4 cell count

  3. Safety

  4. Progression of HIV infection

  5. Pharmacokinetics criteria

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Bristol-Myers Squibb
  • Dupont Applied Biosciences
  • Gilead Sciences
  • Triangle Pharmaceuticals

Registry information

Official study title

Pilot Study on Efficacy and Safety of a Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults. ANRS 091 MONTANA

Important dates

Study start
1999
Study completion
2004
First posted
Sep 20, 2005
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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